Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002865611

FEI Number

3002865611

Entity Name

BALLERSTEDT GMBH

City/State/Country

Reinbek Schleswig-Holstein, DE

Establishment Address

Gutenbergstrasse 34, Reinbek Schleswig-Holstein 21465, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ballerstedt GmbH (Owner Number: 10031943)

Owner / Operator Contact Address

Gutenbergstrasse 34, Reinbek, DE-SH 21465, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NBP extension hose / adapter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2010-03-24

Official Correspondent

Mark Faesel

US Agent Details

John Ferros Business: DRAEGER MEDICAL SYSTEMS, INC. Email: john.ferros@draeger.com Phone: (978) 4828515

Related Public Records

Same Entity

Ballerstedt GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28
K253089	Shenzhen Best Electronics Co., Ltd.	NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)	2026-02-13
K972301	Rudolf Riester GmbH & Co. KG	BIG BEN SQUARE, BIG BEN ROUND	1997-09-17

Similar Registrations

Registration Number	Establishment Name	Location
3031192529	Zhejiang LuDe Technology Development Co., Ltd.	Wenzhou Zhejiang, CN
3009154535	WENZHOU KANGSHUN MEDICAL DEVICES CO.,LTD.	Wenzhou City Zhejiang, CN
1058002	Technicuff Corp.	LEESBURG, FL, US
3001570235	GE Medical Systems Information Technologies, Inc.	Waukesha, WI, US
3012680643	TAIZHOU CHENGUANG IMPORT AND EXPORT TRADING CO., LTD.	Taizhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002865611. Last updated year: 2026. Please use registration number 3002865611 when referencing this establishment in official correspondence.